Faculty Bibliography

OBJECTIVES: This study was designed to assess the safety of arteriotomy closure devices (ACDs) versus mechanical compression by meta-analysis in patients undergoing percutaneous transfemoral coronary procedures. BACKGROUND: Although ACDs are widely applied for hemostasis after percutaneous endovascular procedures, their safety is controversial. METHODS: Randomized, case-control, and cohort studies comparing access-related complications using ACDs versus mechanical compression were analyzed. The primary end point was the cumulative incidence of vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, femoral artery thrombosis, surgical vascular repair, access site infection, and blood transfusion. RESULTS: A total of 30 studies involving 37,066 patients were identified. No difference in complication incidence between Angio-Seal and mechanical compression was revealed in the diagnostic (Dx) setting (odds ratio [OR] 1.08, 95% confidence interval [CI] 0.11 to 10.0) or percutaneous coronary interventions (PCI) (OR 0.86, 95% CI 0.65 to 1.12). Meta-analysis of randomized trials only showed a trend toward less complications using Angio-Seal in a PCI setting (OR 0.46, 95% CI 0.20 to 1.04; p = 0.062). No differences were observed regarding Perclose in either Dx (OR 1.51, 95% CI 0.24 to 9.47) or PCI (OR 1.21, 95% CI 0.94 to 1.54) setting. An increased risk in complication rates using VasoSeal in the PCI setting (OR 2.25, 95% CI 1.07 to 4.71) was found. The overall analysis favored mechanical compression over ACD (OR 1.34, 95% CI 1.01 to 1.79). CONCLUSIONS: In the setting of Dx angiography, the risk of access-site-related complications was similar for ACD compared with mechanical compression. In the setting of PCI, the rate of complications appeared higher with VasoSeal

OBJECTIVES: The present study evaluated clinical outcomes in diabetic patients after multivessel stenting. BACKGROUND: Multivessel angioplasty studies have reported decreased survival in diabetic patients undergoing conventional balloon angioplasty compared with coronary artery bypass graft surgery (CABG). However, several studies have demonstrated excellent procedural success and acceptable clinical outcomes after multivessel stenting. METHODS: Multivessel stenting was performed in 689 patients with 1,639 native coronary lesions. Patients were classified into three groups according to diabetes mellitus (DM) status: 1) no DM (501 patients/1,200 lesions); 2) DM treated with oral agents (102 patients/235 lesions); and 3) DM treated with insulin (86 patients/204 lesions). RESULTS: Procedural success was high overall. In-hospital CABG was higher in diabetics treated with insulin compared with the other two groups (3.5% vs. 0.4% vs. 1.0%, p = 0.02). There were no significant differences in the incidence of in-hospital cardiac death and myocardial infarction. Diabetic patients treated with oral agents or insulin had higher one-year target lesion revascularization rates than non-diabetic patients (25% vs. 35% vs. 16%, p < 0.001). Lower one-year survival was observed in diabetic patients treated with either oral agents or insulin, compared with non-diabetic patients (85% vs. 86% vs. 95%, p < 0.001). On multivariable analysis, DM was an independent predictor of one-year mortality, myocardial infarction, and target lesion revascularization after multivessel stenting. CONCLUSIONS: Despite a high technical success rate of multivessel stenting, diabetic patients, especially those treated with insulin, have higher in-hospital CABG, higher subsequent revascularization rates, and lower one-year survival than non-diabetic patients

Chronic kidney disease (CKD) is a frequent complication of diabetes mellitus. However, the role of CKD in outcomes of patients with diabetes who have undergone percutaneous coronary intervention (PCI) has not been studied specifically. Therefore, we investigated the impact of CKD on prognosis of patients with diabetes who underwent PCI. Of 1,575 diabetic patients who underwent PCI, 1,046 (66%) had preserved renal function, 492 (31%) had CKD (baseline serum creatinine >1.5 mg/dl or estimated glomerular filtration rate <60 ml/min/1.73 m(2)) without dialysis, and 37 (2.3%) were dependent on dialysis. Patients with CKD versus those without CKD had more in-hospital complications, including mortality (2.6% vs 0.5%, respectively; p <0.0001), neurologic events (3.1% vs 0.6%, p = 0.0001), and gastrointestinal bleeding (2.9% vs 0.9%, p = 0.01). Contrast-induced nephropathy after PCI (increase > or =25% and/or > or =0.5 mg/dl of serum creatinine before PCI vs 48 hours after PCI) was found in 15% of patients without CKD versus 27% of those with CKD, and de novo dialysis was instituted in 0.1% versus 3.1%, respectively. Contrast-induced nephropathy was independently predicted (all p <0.0001) by peri-PCI hypotension (odds ratio [OR] 2.62), insulin treatment (OR 1.84), and volume of contrast medium (OR 1.30). The 1-year mortality rate was strikingly higher (all p <0.0001) in patients with CKD who did not receive dialysis (16%) and those on dialysis (44%) compared with the group with preserved renal function (5%). Contrast-induced nephropathy was among the independent predictors of a 1-year mortality rate (OR 2.75, p <0.001)

OBJECTIVES: We sought to develop a simple risk score of contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI). BACKGROUND: Although several risk factors for CIN have been identified, the cumulative risk rendered by their combination is unknown. METHODS: A total of 8,357 patients were randomly assigned to a development and a validation dataset. The baseline clinical and procedural characteristics of the 5,571 patients in the development dataset were considered as candidate univariate predictors of CIN (increase >or=25% and/or >or=0.5 mg/dl in serum creatinine at 48 h after PCI vs. baseline). Multivariate logistic regression was then used to identify independent predictors of CIN with a p value <0.0001. Based on the odds ratio, eight identified variables (hypotension, intra-aortic balloon pump, congestive heart failure, chronic kidney disease, diabetes, age >75 years, anemia, and volume of contrast) were assigned a weighted integer; the sum of the integers was a total risk score for each patient. RESULTS: The overall occurrence of CIN in the development set was 13.1% (range 7.5% to 57.3% for a low [<or=5] and high [>or=16] risk score, respectively); the rate of CIN increased exponentially with increasing risk score (Cochran Armitage chi-square, p < 0.0001). In the 2,786 patients of the validation dataset, the model demonstrated good discriminative power (c statistic = 0.67); the increasing risk score was again strongly associated with CIN (range 8.4% to 55.9% for a low and high risk score, respectively). CONCLUSIONS: The risk of CIN after PCI can be simply assessed using readily available information. This risk score can be used for both clinical and investigational purposes

In-stent restenosis lesions were divided into 2 groups according to the use of cutting balloon (n = 76) or conventional balloon angioplasty (n = 407) before gamma-brachytherapy. Cutting balloon angioplasty, compared with conventional balloon angioplasty, in patients undergoing gamma-brachytherapy for in-stent restenosis is associated with less requirement for new stents (11% vs 22%, p = 0.02) but similar target vessel revascularization (35.1% vs 29.8%, p = 0.4) at follow-up

This study was designed to compare the angiographic outcomes of beta versus gamma vascular brachytherapy (VBT). We reviewed the angiographic results of 636 lesions (212 that underwent beta and 212 that underwent gamma VBT, and 212 that received placebo) with native coronary in-stent restenosis matched for lesion length, vessel size, preprocedure minimum lumen diameter (MLD), and time to angiographic follow-up in the various randomized clinical trials and studies. Baseline lesion complexity was similar in these 3 groups. Final MLD was smaller in the beta VBT group than in the gamma VBT or placebo group. At follow-up, beta and gamma VBT significantly reduced both angiographic restenosis (34.4% for beta VBT, 26.4% for gamma VBT, and 50.9% in the placebo group; p <0.0001) and recurrent lesion length (9.2 mm for beta VBT, 8.4 mm for gamma VBT, and 15.5 mm placebo, p <0.0001) compared with placebo. Gamma VBT was associated with a greater reduction in restenosis outside the stent than beta VBT. By multivariable analysis, independent angiographic predictors of treated segment restenosis included beta or gamma VBT, lesion length, and vessel size. In matched lesions, beta and gamma VBT achieved similar reductions in treated segment restenosis and recurrent lesion length compared with placebo

BACKGROUND: Contrast-induced nephropathy (CIN) is a recognized complication after percutaneous interventions (PCI). We sought to determine the impact of gender on incidence and clinical outcome of CIN. METHODS AND RESULTS: Of a total 8,628 patients who underwent PCI, there were 1,431 (16.5%) who developed CIN (defined as > 25% rise in creatinine after PCI). Patients were followed clinically for one year. CIN was present in 23.6% of female versus 17.4% of male patients (p < 0.0001). Multivariate analysis showed that female gender (OR = 1.4, 95% CI = 1.25 1.60; p < 0.0001), pre-PCI chronic renal failure (CRF) (OR= 1.8, 95% CI = 1.53 2.10, p < 0.0001), diabetes mellitus (OR = 1.5, 95% CI = 1.34 1.70; p < 0.0001), age (OR = 1.01, 95% CI = 1.01 1.02, p < 0.0001), and hypertension (OR = 1.2, 95% CI = 1.06 1.36, p = 0.0035) were independent predictors of CIN. Clinical outcomes after CIN were examined in patients with or without CRF. Among patients without CRF who developed CIN, females (n = 465) had higher rates of one-year mortality, and MACE comparing to males (n = 710) without CRF (14% vs. 10% mortality, 36% vs. 30% MACE; p = 0.05 and 0.06, respectively). In patients with CRF who developed CIN, we found no significant gender differences in one-year clinical events (37% vs. 36% mortality, 42% vs. 45% MACE; p = 0.8 and 0.6, respectively). By multivariate analysis only baseline CRF, diabetes, age, functional NYHA IV class were identified as independent predictors of one-year mortality in patients with CIN after PCI. CONCLUSIONS: Female gender is an independent predictor of CIN development after PCI and a marker of worse 1-year mortality after CIN in patients without baseline CRF. After CIN is developed, pre-PCI CRF, diabetes mellitus, age, severe heart failure (not gender) are independent predictors of one-year mortality

OBJECTIVES: We analyzed the effects of vascular brachytherapy (VBT) on ostial in-stent restenosis (ISR). BACKGROUND: In-stent restenosis has a high recurrence rate after percutaneous reintervention. The recurrence rate of ostial ISR lesions and the impact of VBT remain unknown. METHODS: We evaluated 133 patients with native coronary ostial ISR from a pooled database of 990 patients enrolled in randomized VBT trials. Independent quantitative angiography was performed at baseline and follow-up in 45 gamma, 27 beta, and 61 placebo patients. RESULTS: Binary restenosis was significantly higher in placebo than radiated patients (75.4% vs. 17.8% in gamma vs. 22.2% in beta, p < 0.0001). The treatment effect of both gamma (odds ratio [OR] 0.06; 95% confidence interval [CI] 0.02 to 0.17) and beta VBT (OR 0.10; 95% CI 0.03 to 0.31) was maintained after controlling for differences in baseline lesion length. Proximal and distal radiation edge restenosis rates were similar among the groups. Vascular brachytherapy of true aorto-ostial lesions (n = 34) was similarly beneficial: restenosis rates of placebo versus gamma or beta patients of 83.3% versus 6.7% versus 28.6%, p = 0.0002. CONCLUSIONS: Conventional treatment of ostial ISR is associated with a recurrence rate of over 75%. Vascular brachytherapy with either gamma or beta sources results in significant and similar reductions in restenosis compared with placebo. Similar benefits after VBT prevail in true aorto-ostial lesions

We report the long-term outcome of 225 patients who failed gamma-brachytherapy for in-stent restenosis. Total adverse events, target vessel revascularization, and myocardial infarction were higher after repeat percutaneous coronary intervention versus coronary artery bypass grafting. Therefore, coronary artery bypass grafting may be the preferable first-line therapy in these patients until other therapies (i.e., drug-eluting stents) are available. Shorter time from brachytherapy to radiation failure and late thrombosis after brachytherapy were independent predictors of adverse events